A Prospective, Multicenter Randomized Controlled Trial (RCT) of the da Vinci SP® Surgical System versus Open Surgery in Nipple-Sparing Mastectomy (NSM) Procedures for Patients with Breast Cancer
In brief
Robotic nipple-sparing mastectomy matches open surgery margins, adds one hour
In a multicenter RCT of 140 women, robotic-assisted nipple-sparing mastectomy achieved identical positive-margin rates and comparable 42-day complication rates to open surgery, while preserving the nipple-areolar complex in 100% of cases. Serious adverse events were fewer (3 vs 8), and patient-reported outcomes favored the robotic approach, though differences were not statistically significant.
- Journal
- Annals of surgical oncology (Q1)
- Published
- 16 July 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Katherine Kopkash, Mara Piltin, James Jakub, Sara Javid, Meghan R Flanagan, Rebecca Aft, et al.
- PMID
- 42463607
- DOI
- 10.1245/s10434-026-20201-6
Why clinicians should know about it
- Picked for Pathology and Forensic Medicine (top studies of the week, 19 July 2026).
Abstract
BACKGROUND: This prospective randomized trial evaluated the safety and effectiveness of robotic-assisted nipple-sparing mastectomy (rNSM) using the da Vinci Single Port (SP)® compared with open NSM in women with early stage breast cancer. PATIENTS AND METHODS: This Food and Drug Administration (FDA) investigational device exemption (IDE)-approved, two-arm, multicenter randomized controlled trial (RCT) randomized eligible women (clinical Tis-T2, N0) 1:1 to rNSM or open NSM with immediate implant-based reconstruction. Operations were performed at 14 US sites by 23 surgeons. Primary endpoints included conversion to open surgery, adverse events at 42 days, and positive surgical margin (PSM) rates. Secondary outcomes included operative time, estimated blood loss, nipple-areolar complex (NAC) and skin flap viability, final pathology, and patient-reported outcomes (BREAST-Q). RESULTS: Overall, 74 patients completed surgery, totaling 65 rNSM (38 therapeutic, 27 prophylactic) and 66 open NSM (38 therapeutic, 28 prophylactic). Operative time was longer for rNSM (141.6 versus 83.9 min) with no conversions to open surgery. Serious adverse events (SAEs) occurred in three rNSM and eight open NSM patients, with no device-related SAEs reported. NAC preservation at 42 days was 100% for rNSM and 98.5% for open NSM. PSM rates were identical (six patients each). Higher BREAST-Q scores favored rNSM in multiple domains. CONCLUSIONS: These results demonstrate that da Vinci SP® rNSM is feasible and has a safety profile comparable to open NSM for early stage breast cancer, with similar margin status and postoperative complications. Although SAEs and patient-reported outcomes were more favorable with rNSM, these differences were not statistically significant. rNSM was associated with longer operative times, which may in part reflect early experience with the technique.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.